510(k) K153388 ยท FMI Needle, Hypodermic, Single Lumen
IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle
| Applicant | Guangzhou Improve Medical Instruments Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Jun 7, 2016 |
| Received | Nov 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153388
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.